CIMdata PLM Industry Summary Online Archive
29 January 2007
Product News
FastTrakT CAPA Hits the Market; Another Solution from the Integware FastTrakT Family, Supporting Product Lifecycle Management and Quality Solutions in the Medical Device Industry
Integware , a leading provider of Product Lifecycle Management (PLM) consulting and implementation services, knows what a solid CAPA system can do for a medical device company. "Through our consulting work for a number of leading medical device companies, all say the same thing, our biggest pain point is managing our CAPA's, so we decided to do something about it" said Chris Kay, CEO of Integware.
FastTrakT CAPA can be purchased as a single module or as a bundle with other FastTrakT products (FastTrakT NCR, FastTrakT Change, FastTrak Med DeviceT). Whatever the need, Integware delivers integrated best-in-class PLM-based solutions designed for your company's specific product lifecycle processes. "To support process excellence initiatives, the CAPA process needs to interact with all aspects of product development, from design through manufacturing to support." said Max Huff, Senior Consultant. Integware provides the only CAPA solution with process integration capabilities beyond just the quality organization to meet the needs of FDA regulated companies.
Integware's FastTrakT CAPA allows for integration with other Quality Management Solutions (such as FastTrakT NCR, Change, Complaints, Quality Audits, Verification and Validation and BOM Configurator) and all other PLM solutions within the FastTrakT suite. This system promotes the adoption of the preventive mind-set. "Companies are now able to move toward taking preventive actions vs. just correcting issues that have already happened" said Chris Kay.
Integware's FastTrakT CAPA is currently in global production for several leading medical device manufacturers. FastTrakT CAPA is the result of years of providing CAPA and many other compliance and product lifecycle solutions to leading medical device companies around the world. This solution enables organizations to manage the CAPA process across the entire company, helping you meet FDA regulatory requirements, increase efficiency and reduce costs. Each FastTrakT solution comes complete with documentation, training and validation, making your investment painless for your organization.
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